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NCT00880620 · ClinicalTrials.gov registry record · Phase 3
A Study To Evaluate The Safety And Efficacy Of IPX066 In Subjects With Parkinson's Disease
A Phase 3 study, sponsored by Impax Laboratories.
- Completed
- Registry status
- Phase 3
- Development phase
- 381
- Enrollment target
NCT00880620: Completed Phase 3 study, sponsored by Impax Laboratories.
NCT00880620 is a Phase 3 study that has completed, run by Impax Laboratories. The registered enrollment target is 381 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (51% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00880620, a Phase 3 study, has completed, sponsored by Impax Laboratories.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 381 participants
- Enrollment target
Study Summary
This study examines the efficacy of three doses of IPX066 as compared to placebo in Parkinson's disease.
Primary Outcome
Analysis of the Change from Baseline in the sum of the Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living) + UPDRS Part III (Motor Examination) at Week 30 (End of Study). Unified Parkinson's Disease Rating Scale (UPDRS) - Four Parts Higher score values represent a worse outcome. Subscales II and III were summed: Part I: Mentation, Behavior and Mood - 4 questions 1-4 Score range: 1-16 Part II: Activities of Daily Living - 13 questions 5-17 Score range: 0-52 Pa
Interventions
- DRUG Placebo
- DRUG IPX066 95 mg LD
- DRUG IPX066 145 mg LD
- DRUG IPX066 195 mg LD
- DRUG IPX066 245 mg LD
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 381 participants |
| Start Date | 2009-04 |
| Est. Completion | 2010-11 |
| Phase | Phase 3 |
What the finished NCT00880620 record still lists
NCT00880620 is an interventional study that assigns participants to a tested intervention. The registered 381 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (51% lower).
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT00880620 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00880620 about?
NCT00880620 is a clinical study titled "A Study To Evaluate The Safety And Efficacy Of IPX066 In Subjects With Parkinson's Disease". This study examines the efficacy of three doses of IPX066 as compared to placebo in Parkinson's disease.
What is the current status of trial NCT00880620?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 381 participants. The study started on 2009-04. Estimated completion is 2010-11.
What interventions are being tested in trial NCT00880620?
The interventions under investigation include: Placebo (DRUG), IPX066 95 mg LD (DRUG), IPX066 145 mg LD (DRUG), IPX066 195 mg LD (DRUG), IPX066 245 mg LD (DRUG).
Who is sponsoring clinical trial NCT00880620?
This trial is sponsored by Impax Laboratories, which has 19 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00880620's enrollment target sits among peer trials
381 982nd of 2000 higher than 1,018 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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